Detection of Hyperkalemia Powered by AI Receives FDA Breakthrough Designation AccurKardia, a leading innovator in ECG-based diagnostic technology, has announced that its AI-powered AK+ Guard™ hyperkalemia detection software has received Breakthrough Device Designation from the U.S. Food and Drug Administration…
Diality Treats First Patient with Moda-flx Hemodialysis System Diality, a cutting-edge medical device company specializing in smart, flexible hemodialysis platforms, has announced the successful completion of the first-ever patient treatment with its Moda-flx Hemodialysis System™. This milestone was achieved in…
Stoke Therapeutics Announces Phase 3 Study Plans for Zorevunersen in Dravet Syndrome Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company focused on RNA medicine to restore protein expression, announced today that it has finalized its Phase 3 EMPEROR study design…
Heart Failure Program and Leadership Change Announced by RyCarma RyCarma Therapeutics, Inc., formerly known as ARMGO Pharma, is a clinical-stage biotech company focused on developing first-in-class small molecule therapeutics for cardiovascular and skeletal muscle diseases. Today, the company announced its…
Announces REZZAYO® Approval in Spain for Invasive Candidiasis Treatment by Mundipharma Mundipharma announces today that Spain’s Ministry of Health has approved reimbursement for REZZAYO® (rezafungin acetate) as a treatment for invasive candidiasis in adults. This announcement follows the European Commission’s…
Arcturus Begins Phase 2 Dosing for CF and OTC Deficiency Arcturus Therapeutics Holdings Inc., a pioneering company in mRNA medicine, announced that it has initiated Phase 2 multiple ascending dose studies for two major conditions—cystic fibrosis (CF) and ornithine transcarbamylase…
Collaboration Between Team Gleason and Synchron Expands BCI Efforts Synchron, a leading brain-computer interface (BCI) company, and Team Gleason, a foundation focused on enhancing the lives of individuals living with Amyotrophic Lateral Sclerosis (ALS), have expanded their partnership to promote…
NanoVibronix Completes UroShield® Pilot Study at University of Michigan NanoVibronix, Inc. (NASDAQ: NAOV), a medical device company specializing in portable ultrasonic therapeutic devices such as UroShield®, PainShield®, and WoundShield®, has announced the successful completion of the first phase of a…
Conference Preview: Avenacy Updates 2025 Strategy Ahead of J.P. Morgan Healthcare Event Avenacy, a specialty pharmaceutical company focused on providing critical injectable medications, has shared updates regarding its recent business achievements, financial performance for 2024, and strategic priorities for 2025.…
FDA Grants Fast Track to Star Therapeutics for VGA039 in VWD Star Therapeutics, a clinical-stage biotechnology company focused on developing cutting-edge antibodies, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VGA039, an…
UK Grants Conditional Approval for Amgen’s Tarlatamab in SCLC Amgen has announced that its bispecific antibody, IMDYLLTRA® (tarlatamab), has received conditional marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adult patients with…
Esophagus Test TissueCypher® Receives NY State Approval, Announces Castle Biosciences Castle Biosciences, Inc. (Nasdaq: CSTL), a leading company in providing innovative tests to guide patient care, has announced that its TissueCypher® Barrett’s Esophagus test has been approved by the New…